# K261011: Sleep Apnea Feature (v2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jul 20, 2026 after 116 days
- Product code: QZW (Over-The-Counter Device To Assess Risk Of Sleep Apnea)
- Device class: 2
- Regulation: 21 CFR 868.2378
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN230041 (2024). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230041: Sleep Apnea Feature, Samsung Electronics Co., Ltd. (2024) Summary page 5.
- K240929: Sleep Apnea Notification Feature (SANF), Apple, Inc. (2024) Summary page 5.

## Indications for use
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Wearable and Phone. This feature is intended to detect signs of moderate to severe sleep apnea in the form of significant breathing disruptions in users 18 years and older, over a two-night monitoring period. It is intended for on-demand use and requires two nights of valid data within a 10-day period. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician.

Source page: https://510kreport.com/device/K261011
Methodology: https://510kreport.com/methodology